Virus-Serum-Toxin Act 

21 USC 151-159 et. seq. 

CHAPTER 5. VIRUSES, SERUMS, TOXINS, ANTITOXINS, AND ANALOGOUS 

PRODUCTS 

151. Preparation and sale of worthless or harmful products for domestic products for 

animals prohibited, preparation to be in compliance with rules at licensed establishments 

152. Importation regulated and prohibited 

153. Inspection of imports; denial or entry and destruction 

154. Regulations for preparation and sale; licenses 

154a. Special licenses for special circumstances; expedited procedure; conditions; 

exemptions; criteria 

155. Permits for importation 

156. Licenses condition on permitting inspection; suspension of licenses 

157. Same; inspection daytime or nighttime 

158. Offenses; punishment 

159. Corporations; commerce; trade 

(37 Stat. 832-833; as amended December 23, 1985, Pub. L. 99-198, 99 Stat.1654-1655; 

21 U.S.C. 151-159). 

151. Preparation and sale of worthless or harmful products for domestic animals 

prohibited; preparation to be in compliance with rules at licensed establishments. 

It shall be unlawful for any person, firm or corporation to prepare, sell, barter, or 

exchange in the District of Columbia, or in the Territories or in any place under the 

jurisdiction of the United States, or to ship or deliver for shipment in or from the United 

States, the District of Columbia, any territory of the United States, or any place under the 

jurisdiction of the united States, any worthless, contaminated, dangerous, or harmful 

virus, serum, toxin, or analogous product intended for use in the treatment of domestic 

animals, and no person, firm, or corporation shall prepare, sell, barter, exchange, or ship 

as aforesaid any virus, serum, toxin, or analogous product manufactured within the 

United States and intended for use in the treatment of domestic animals, unless and until 

the said virus, serum, toxin, or analogous product shall have been prepared, under and in 

compliance with regulations prescribed by the Secretary of Agriculture, at an 

establishment holding an unsuspended and unrevoked license issued by the Secretary of 

Agriculture as herein after authorized. 

152. Importation regulated and prohibited. 

The importation into the United States, without a permit from the Secretary of 

Agriculture, of any virus, serum, toxin, or analogous product for use in the treatment of 

domestic animals, and the importation of any worthless, contaminated, dangerous, or 

harmful virus, serum, toxin, or analogous product for use in the treatment of domestic 

animals, are hereby prohibited. 
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153. Inspection of imports; denial of entry and destruction. 

The Secretary of Agriculture is hereby authorized to cause the Bureau of Animal Industry 

to examine and inspect all viruses, serums, toxins, and analogous products, for use in the 

treatment of domestic animals, which are being imported or offered for importation into 

the United States, to determine whether such viruses, serums, toxins, and analogous 

products are worthless contaminated, dangerous, or harmful, and if it shall appear that 

any such virus, serum, toxin, or analogous product, for use in the treatment of domestic 

animals, is worthless, contaminated, dangerous, or harmful, the same shall be denied 

entry and shall be destroyed or returned at the expense of the owner or importer. 

154. Regulations for preparation and sale; licenses. 

The Secretary of Agriculture is hereby authorized to make and promulgate from time to 

time such rules and regulations as may be necessary to prevent the preparation, sale, 

barter, exchange, or shipment as aforesaid of any worthless, contaminated, dangerous, or 

harmful virus, serum, toxin, or analogous product for use in the treatment of domestic 

animals, or otherwise to carry out this paragraph, and to issue, suspend, and revoke 

licenses for the maintenance of establishments for the preparation of viruses, serums, 

toxins, and analogous products, for use in the treatment of domestic animals, intended for 

sale, barter, exchange, or shipment as aforesaid. 

154a. Special licenses for special circumstances; expedited procedure; conditions; 

exemptions; criteria. 

In order to meet an emergency condition, limited market or local situation, or other 

special circumstance (including production solely for intrastate use under a State 

program), the Secretary may issue a special license under an expedited procedure on such 

conditions as are necessary to assure purity, safety, and a reasonable expectation of 

efficacy. The Secretary shall exempt by regulation from the requirement of preparation 

pursuant to an unsuspended and unrevoked license any virus, serum, toxin, or analogous 

product prepared by any person, firm, or corporation-- 

(1) solely for administration to animals of such person, firm, or corporation; 

(2) solely for administration to animals under a veterinarian-client-patient relationship in 

the course of the State licensed professional practice of veterinary medicine by such 

person, firm, or corporation; or 

(3) solely for distribution within the State of production pursuant to a license granted by 

such State under a program determined by the Secretary to meet the criteria under which 

the State-- 

(A) may license virus, serum, toxin, and analogous products and establishments that 

produce such products; 

(B) may review the purity, safety, potency, and efficacy of such products prior to 

licensure; 

(C) may review product test results to assure compliance with applicable standards for 

purity, safety, and potency prior to release to the market; 

(D) may deal effectively with violations of State law regulating virus, serum, toxin, and 

analogous products; and 

(E) exercises the authority referred to in subclauses (A) through (D) consistent with the 
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intent of this paragraph of prohibiting the preparation, sale, barter, exchange, or shipment 

of worthless, contaminated, dangerous, or harmful virus, serum, toxin, or analogous 

products. 

155. Permits for importation. 

The Secretary of Agriculture is hereby authorized to issue permits for the importation 

into the United States of viruses, serums, toxins, and analogous products, for use in the 

treatment of domestic animals, which are not worthless, contaminated, dangerous, or 

harmful. 

156. Licenses conditioned on permitting inspection; suspension of licenses. 

All licenses issued under authority of this chapter to establishments where such viruses, 

serums, toxins, or analogous products are prepared for sale, barter, exchange, or shipment 

as aforesaid, shall be issued on condition that the licensee shall permit the inspection of 

such establishments and of such products and their preparation; and the Secretary of 

Agriculture may suspend or revoke any permit or license issued under authority of said 

chapter, after opportunity for hearing has been granted the licensee or importer, when the 

Secretary of Agriculture is satisfied that such license or permit is being used to facilitate 

or effect the preparation, sale, barter, exchange, or shipment as aforesaid, or the 

importation into the United States of any worthless, contaminated, dangerous, or harmful 

virus, serum, toxin, or analogous product for use in the treatment of domestic animals. 

157. Same; inspection daytime or nighttime. 

Any officer, agent, or employee of the Department of Agriculture duly authorized by the 

Secretary of Agriculture for the purpose may, at any hour during the daytime or 

nighttime, enter and inspect any establishment where any virus, serum, toxin, or 

analogous product for use in the treatment of domestic animals is prepared for sale, 

barter, exchange, or shipment as aforesaid. 

158. Offenses; punishment. 

Any person, firm, or corporation who shall violate any of the provisions of this chapter 

shall be deemed guilty of a misdemeanor, and shall, upon conviction, be punished by a 

fine of not exceeding $1,000 or by imprisonment not exceeding one year, or by both such 

fine and imprisonment, in the discretion of the court. 

159. Enforcement, penalties applicable. Congressional findings. 

The procedures on sections 672, 673, and 674 of this title (relating to detentions, seizures 

and condemnations, and injunctions, respectively) shall apply to the enforcement of this 

chapter with respect to any product prepared, sold, bartered, exchanged, or shipped in 

violation of this chapter or a regulation promulgated under this chapter. The provisions 

(including penalties) of section chapter 675 of this title shall apply to the performance of 

official duties under this paragraph. Congress finds that (1) the products and activities 

that are regulated under this chapter are either in interstate or foreign commerce or 

substantially affect such commerce or the free flow thereof and (ii) regulations of the 

products and activities as provided in this chapter is necessary to prevent and eliminate 

burdens on such commerce and to effectively regulate such commerce. 
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This section is effective on December 23, 1985, except that: 

(1) Subject to subparagraphs (2) through (4), in the case of a person, firm or corporation 

preparing, selling, bartering, exchanging, or shipping a virus, serum, toxin, or analogous 

product during the 12 month period ending on the date of enactment of this Act solely for 

intrastate commerce or for exportation, such product shall not after such date of 

enactment, as a result of its not having been licensed or produced in a licensed 

establishment, be considered in violation of the eighth paragraph of the matter under the 

heading BUREAU OF ANIMAL INDUSTRY" of the Act entitled The Virus- SerumToxin Act. 

An Act making appropriations for the Department of Agriculture for fiscal year ending 

June thirtieth, nineteen hundred and fourteen", approved March 14, 1913 (as amended by 

this section), until the 1st day of the 49th month following the date of enactment of this 

Act. 

(2) The exemption granted by subparagraph (1) may be extended by the Secretary of 

Agriculture for a period up to 12 months in an individual case on a showing by a person, 

firm, or corporation of good cause and a good faith effort to comply with such eighth 

paragraph with due diligence. 

(3) The exemption granted by subparagraph (1) must be claimed by the person, firm, or 

corporation preparing such product by the 1st day of the 13th month following the date of 

enactment of this Act, in the form and manner prescribed by the Secretary, unless the 

Secretary grants an extension of the time to claim such exemption in an individual case 

for good cause shown. 

(4) On the issuance by the Secretary of a license to such person, firm, or corporation for 

such product prior to the 1st day of the 49th month following the date of enactment of 

this Act, or the end of an extension of the exemption granted by the Secretary, the 

exemption granted by subparagraph (1) shall terminate with respect to such product.